Cranial flap fixation with bioresorbable bone adhesive study
Part of Injuries & trauma clinical trials.
This trial is testing a new, dissolvable bone glue to fix bone flaps back in place after skull surgery. It may help people who need a planned skull procedure (craniotomy) in the upper part of the head.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are between 18 and 75 years old.
- You are scheduled for a planned skull surgery in the upper part of your head (not through the nose, ear, or sinus).
- Your surgery involves a clean, uninfected wound.
- You have not had open brain surgery in the same spot before (a small biopsy is okay).
- You have not had radiation therapy to the surgical area, and no full-course radiation is planned right after surgery.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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This study is testing a patch called Tutopatch used during craniotomy, a surgery that opens part of the skull. The goal is to gather more information about how well it works after it is already approved for use.
This trial tests a special 3D bone graft material to repair skull defects after brain surgery. It may help people who need a strong, custom-fit implant to protect their brain.
This study tests a new bone paste called Montage Flowable that helps hold the piece of skull bone in place after brain surgery. It may be an option for people having surgery on the upper part of the brain who are not eligible for other methods.
This trial tests a new medical device that helps guide surgery for children with certain skull conditions (trigonocephaly or anterior plagiocephaly). The device is designed to make the surgery safer and more precise for children aged 4 to 24 months.
This trial tests a product called CraniSeal, which is used to help seal the covering of the brain (the dura) after surgery. It may lower the risk of fluid leaks after certain types of planned brain surgeries.
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